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Advantages And Disadvantages Of Bayh Dole

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March-in-Rights The March-in right is one of the most contentious provisions in Bayh-Dole . It give the federal government the right to grant additional licenses to other "reasonable applicants" or give a license to themselves if they aided the owner of a patent with funding. If march-in rights are used by the government they are required to pay royalties to the patent holder. This is a form a patent protection that not even the federal government can just take away. This right is strictly limited and can only be exercised if the agency determines, following an investigation, that one of four criteria is met :- 1) Action is necessary because the contractor or assignee has not taken, or is not expected to take within a reasonable time, effective …show more content…

Out of these four, the most important of these is a failure by the contractor to take "effective steps to achieve practical application of the subject invention" or a failure to satisfy "health and safety needs" of consumers. Apart from public safety issues, government may exercise this on:- 1) Small business or non-profit which are funded by …show more content…

But for rare occasions, the government’s position is also clear, like when “You have to make a decision between having drugs at a high price and having no drugs at all”. The two major provider of research dollars for the development of such inventive treatments i.e. American Association for the Advancement of Science (AAAS) and the National Institute of Health (NIH) is at the centre of this debate. It is interesting to note that, the NIH has received five such march-in requests and has denied every one. This contention of NIH maintains the stand of the government that the march-in right is not a cost control measure but rather a measure to ensure federally funded inventions being made available to the public. What to do to avoid March-in-Right An individual who is looking to patent an item but does not want to deal with the possibility of march-in rights has to be sure of a few things in order to avoid being subject to

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A new oral pharmaceutical drug for type- two diabetes had been approved for clinical use, it was called Compound 17392. Marketing companies instantly wanted to have prescribers adopt and sell the product and researchers wanted to further investigate previous reports of liver toxicity in patients. Now since paying patients to try new pharmaceutical drugs was an issue due to it appearing to interfere with clinical judgement and upholding the duty to do what is best for the patient, a new idea of furthering research for the drug came into play. The idea included recruiting a group of physicians who were in the top ten percent of prescribers for type-two diabetes. Following regulations put in place by researchers, these physicians were to enter eligible patients into the trial for Compound

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1146 Words | 5 Pages

To demonstrate this, Skloot mentions, “the ruling didn’t prevent commercialization; it just took patients out of the equation and emboldened scientists to commodify tissues in increasing numbers”. It becomes apparent that taking a doctor to court in the 1950s often had no effect, except that the doctor would be more reluctant to share his or her research with fellow scientists. Today, however, there are more laws in place and if a doctor was found to have broken the law, her or she would lose their medical

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1785 Words | 8 Pages

The essay “Best Hope Lies in Privately Funded Stem Cell Research”, states the importance of stem cell research and the effects it can have on curing disease more effectively than any other method. Written by Sigrid Fry-Revere, PhD, director of bioethics studies at the Cato Institute; the author of the paper emphasizes the importance of funding programs for stem cell research on highlights the government holding out on funding due to ethical reasons. Revere claims that the government is threatening the private investing of stem cell research organizations and are trying to put a stop to production of research. This essay is targeted for people who are academic/bioethics orientated and the future of the world disease control and abolishment.

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976 Words | 4 Pages

“In 1981, the U.S Department of Health and Human Services enacted regulations for the protection of human subjects, known as the “Common Rule,” which establish the standard governing research that is supported by federal government,” (Rao). Because of cases such as this, the government now has in place several federal laws protecting the rights of patients. If it were not for these laws, doctors would have more control over what is done with our bodies than

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1408 Words | 6 Pages

“the public will be largely undefended against the aggressive and potentially dangerous predations of multibillion-dollar conglomerates.” Companies who make billions of dollars just by selling their drugs can take advantage of this and rush to get their drug out there without it even working

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251 Words | 2 Pages

I am regarding the Ensuring Access to Clinical Trials Act of 2015 for Rare Diseases. H.R. 209 [114th] I am writing you to ask that you help pass the new bill. The cruel disease Cystic Fibrosis (a life-threatening, genetic disease that causes persistent lung infections and progressively limits the ability to breathe) effects about 30,000 people living with Cystic Fibrosis (70,000 worldwide), approximately 1,000 new cases of Cystic Fibrosis are diagnosed each year. In the past two years I have met

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501 Words | 3 Pages

Level headed discussions are extraordinary over how the area is relied upon to work. In this amount driving records in area, NGOs, government, the restorative group, and scholarly world open deliberation and propose answers for the ethical issue of medication industry lead. They investigate such perspectives as the capacity of patent assurance and protected innovation rights, the morals and monetary essentials of study and restorative trials, medicate showcasing, promoting, and

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132 Words | 1 Pages

Some of the pros of the government safety regulations include enforcing standards that are equally applied across all organizations which will eventually help maintain ecological balance. As these regulations are enforced legally, it requires the firms to meet them or they will be fined or shut down. There are some disadvantages associated with the regulations as well, These include: 1) Establishing of standard and fair rules across multiple organizations requires intensive studies, analysis, documentation and legal proceedings which might be time consuming 2) As these rules and regulations are fair to all, this raises a concern around their effectiveness 3) Regulations can take away any industry's incentive to do more than the minimum

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516 Words | 3 Pages

The right to engage in such contract is protect under the 14th amendment specifically the liberty right; the liberty to engage in business contracts. Justice Peckham uses Allgeyer v. Louisiana to explain the concept of liberty. Setting work hours is understood as the purchase or sell of labor. However, Justice Peckham explains, there are instances where this liberty right can be deny under state powers. He classifies the state power as police powers consisted of maintaining safety, health, morals, or general welfare of the state.

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562 Words | 3 Pages

It supposes important progress in the fight against diseases such as diabetes, some cancers and others hereditary diseases. Although they have many advantages, they also pose ethical problems, often motivated by the interests and bad practices of multinational

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The context today includes the amazing scientific and technological advances in medicine, as well as the systems for their development and deployment. Medicine, in utilizing technological advances needs to consider people as well as profit. Technology is treated in Section 5, Section 6, and Section 7. Changes in the delivery of medical care have resulted in increasingly centralized control and regulation of medical care.

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There has been controversy over the claims made for some patents, for example, Myriad Genetics patents over the BRCA1 and BRCA2 genes . Myriad has used its patents to attempt to limit any other company from conducting breast cancer gene tests for these two genes, and they cover both genes and proteins and are claiming to cover the modes of action of the genes as well. This issue has faced strong criticism , on the grounds of morality Patent regulation provides numerous examples of how policy decisions have consequences that run counter to what was intended by the makers or supporters of those decisions, most the time they’re intended with a good cause in mind but up otherwise. One reason stems from the fact that when powerful and organized business interests consider that a new reform hinders their opportunities and they are unable to influence policy makers, interests (Myriad). They may achieve this through alternative legal means or by the adoption of new

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720 Words | 3 Pages

A company needs to go through extensive regulatory approval, licensing, high financial backing and investment, an effective distribution network, brand patents and strong brand presence make it a difficult industry to enter or exit. This is why the threat of a new entrant is low to moderate to existing companies. Based on factors mentioned above. But now many pharmaceutical companies are progressing in the market by shifting from traditional business approach to emerging new business approach. The new business technique includes contract research (drug discovery and clinical trials), contract manufacturing and co-marketing alliance.

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2141 Words | 9 Pages

blah states “Increased competition is proven to result in lower prices, which in turn contribute to improved access to medicines”, it was the Developed Nations which benefited from the profit gained from using the resources of the developing nations. Prohibitive drug prices are often the result of strong intellectual property protection. It is therefore unsurprising that places like the United Nations, Japan, China and a few in Western Europe, have fought for stronger control and higher levels of property rights laws. These nations argue for strong global protection, as they have

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1120 Words | 5 Pages

These assessments are often poor. Alternatives put forward tend to be unrealistic in order to favour the option the applicant wants to implement. The regulations also require the applicant to illustrate the need and desirability of the project, which is often not done (Hutton and Tefford, 2003). Impact mitigation Insufficient information provided on recommended mitigation measures; little indication of the practicality, reliability and potential effectiveness of the mitigation measures and problems with measures which are recommended that don’t address identified impacts.

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